Clinical trial · Interventional
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to evaluate the efficacy of SHR-A2102 for injection combined with Adebrelimab compared with gemcitabine combined with cisplatin in the treatment of muscular invasive bladder cancer (MIBC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscular Invasive Bladder Cancer (MIBC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A2102；Adebrelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab
- interventionNames
- Drug: SHR-A2102；Adebrelimab
Primary outcomes (2)
- measure
- Phase II: pCR evaluated by researchers;
- timeFrame
- Three months after the last subject underwent RC+PLD surgery
- measure
- Phase III: EFS assessed by BICR；
- timeFrame
- 5 years after the first medication of the last subject
Secondary outcomes (8)
- measure
- ORR
- timeFrame
- from first dose to disease progression or death, whichever comes first, up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: \- 1.18-80 years old, gender not limited. 2.The patient voluntarily joined this study and signed informed consent 3.ECOG score is 0 or 1 4.Expected survival period ≥ 2 years. 5.Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer 6.There are assessable lesions that meet the RECIST 1.1 criteria 7. Enough organ function Exclusion Criteria: 1. Received systemic anti-tumor therapy 4 weeks before starting the study treatment 2. The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level 3. Subjects known or suspected to have interstitial pneumonia 4. Individuals with any active, known or suspected autoimmune diseases 5. There are clinical symptoms or diseases of the heart that have not been well controlled 6. Diagnosed with any other malignant tumor 7. Subjects who have experienced severe infections within 28 days prior to their first medication use 8. History of immunodeficiency 9. Use of attenuated live vaccine within 28 days prior to the first study medication 10. Have undergone major surgery within 28 days prior to the first administration of medication
References
Publications (0)
Data not yet available